Bardia® Foley Catheter Silicone Coated 123628ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741095252), received between Mar 18, 2021 and Jul 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS NOT DEFLATING PROPERLY. PER CUSTOMER VIA PHONE ON (B)(6) 2021 IT WAS STATED THAT THERE WERE 3 CATHETERS WHERE IT TOOK ABOUT ONE HOUR FOR THE BALLOON TO DEFLATE. NO MEDICAL INTERVENTION WAS REQUIRED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247615 ↗
• MalfunctionMar 18, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE BALLOON WAS DEFLATING. PATIENT WAS NOT INJURED AND ANOTHER NEW FOLEY WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516814 ↗